Lotus Foundations Deployment — The Lotus Foundations release and deployment of Winchester’s FastCTMS is based on IBM’s Lotus Foundations (LF). Winchester’s Lotus Foundations FastCTMS makes a lot of sense if you are:

• Interested in having a system that does not require internal IT services
  
• Sponsor whose clinical trials are growing from Phase II to Phase III
  
• CRO managing clinical trials
  
• In need "spreadsheet-like" information
  
• In need of the trial team to use one system
  
• Concerned about how much to spend
  
• Apprehensive about "How to deploy CTMS to all of our CRAs and partners at once?"
  
  

Winchester is a business partner with IBM delivering FastCTMS on the IBM Lotus Foundations platform which is directed toward the small to medium business marketplace. Lotus Foundations-based FastCTMS includes several components including a start-up server with most everything a new client needs already configured and running for them.

Winchester’s FastCTMS can be delivered to your site preconfigured for your environment. Customers do not need to install a separate VPN or LAN to facilitate the system.

IBM Lotus Foundations Start and FastCTMS delivers essential software required to run a small business. The amalgamation provides a unique combination of reliability, security, and simplicity while helping to reduce cost and complexity.

Whether you need to set up an office network, connect branch offices, protect your data, or provide remote access, e-mail, and collaboration capabilities to employees, Lotus Foundations Start can help.

• Run your business on a reliable and security-rich server. An extremely small server footprint and a Linux™-based operating system provide high reliability, security features, and business continuity.
• Help save time and costs in manual day-to-day IT management, while adding simplicity and reliability to your IT infrastructure. The unique self-managing autonomics reduces IT complexity, automating many critical functions including installation, configuration, security checks, and overall system management.
• Facilitate the creation and sharing of information in your company. Easily share calendars and schedule meetings with IBM Lotus Notes® and Domino® collaboration software.
• Help reduce cost of ownership with Lotus office productivity tools. Work on spreadsheets, presentations, and documents without purchasing expensive office software or upgrades.
• Have the peace of mind that your data is reliably backed up with frequent automated disk backups, and in the event of a disaster, usually execute a full system recovery within minutes.
• Protect your business with integrated firewall, antivirus, and antispam software.
  
  

Adverse Events — Adverse Events and Serious Adverse Events must be properly tracked and reported on a trial. Protocol Manger comes enabled with the configurable (optional) ad-Watch-AE safety system. From within this module an adverse event may be reported, encoded, and submitted to the FDA or other health agency electronically.

Trial Master File — FastCTMS provides a configurable link to Winchester’s paraFILE document management and repository system. This option is configured and then exercised when the clinical trial team determines that they wish to “publish” FastCTMS-managed records, documents, and attached files to the Trial Master File (TMF). Most published documents will be published in the pdf-file format. Integration Components — FastCTMS has been interfaced with many other organizations’ software products:

• EDC Integration — FastCTMS has often been interfaced with popular, commercial EDC systems. In some cases, FastCTMS has been interfaced with client-developed, in-house EDC systems. The integration with EDC systems provides the clinical trial managers with the ability to determine the instant status of any component of a trial.
  
  
• Excel Integration — FastCTMS comes equipped with an Export to Microsoft Excel® feature for almost any data or document components contained anywhere in the system. This integration provides the maximum flexibility in reporting for users who are familiar with Microsoft Excel.
  
  
• Word Integration — FastCTMS is equipped with an active interface with Microsoft Word®. This interface is in place for the management of document templates, direct mail directly driven from FastCTMS, and mail merge.
  
  
• Cognos BI Integration — Dashboards and scorecards are available through an active inter-face with Cognos’ Business Intelligence system. This web-based interface allows interested users to “slice and dice” program and project information to satisfy corporate reporting requirements.
  
  To request a demo, click here.
  
  To download the brochure, click here.
  
  To view an interactive flash presentation on Protocol Manager, click here.